RecruitingPhase 2Phase 3NCT04982419

Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial


Sponsor

VA Office of Research and Development

Enrollment

240 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, double-blind, sham-controlled, multicenter, randomized clinical trial is to study the effects of remote ischemic preconditioning on contrast-associated acute kidney injury, functional capacity, and major adverse kidney events in in patients with congestive heart failure undergoing cardiac catheterization and/or percutaneous coronary intervention.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Age 18 years
  • Diagnosis of heart failure with reduced LVEF \<50%
  • Pre-procedure intravenous normal saline fluid restriction status
  • Society for Cardiovascular Angiography and Interventions (SCAI) AKI risk score (\>1%)
  • Referral for coronary angiogram and/or PCI
  • Suspected stable coronary artery disease or acute coronary syndrome

Exclusion Criteria9

  • Inability to give informed consent
  • Unstable BP (SBP \> 200 or \<80 mmHg) at the time of enrolment
  • Upper limb peripheral arterial disease
  • Unavailability of at least one arm for RIPC/Sham-RIPC application
  • Kidney transplant
  • Renal disease requiring dialysis
  • Prior exposure to contrast media within 72hrs preceding coronary angiography
  • Pregnancy
  • Prisoner

Interventions

DEVICERemote ischemic preconditioning

3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes

DEVICESham remote ischemic conditioning

3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)


Locations(3)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT04982419


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